Catheter assembly for peritoneal cavity insertion

ABSTRACT

A catheter assembly for peritoneal insertion, including an elongated stylet, an elongated catheter slidably disposed around the stylet and a gripping member secured to a proximal end of the stylet and having a handle grip extending transversely therefrom adjacent a shank of the stylet such that the handle grip may be grasped in the palm of one hand with the fingers grasping the catheter adjacent a distal end thereof whereby the catheter assembly may be firmly held and guided with one hand during peritoneal cavity insertion. Various embodiments of the catheter assembly include an elongated barrel surrounding the catheter having a closed end anchored to the proximal end of the stylet, a stylet which is bent upon itself to form the gripping member, and a gripping member disposed parallel to the shank of the stylet and having an upper end bent upon itself and secured to the proximal end of the stylet.

CATHETER ASSEMBLY FOR PERITONEAL CAVITY INSERTION [72] Inventors: DeanR. Katerndahl, Wheaton; Earl D. Wilson, lngelside; Fidel V. Macalalad,Lake Forest; Gene C. Ring, Libertyville, all of 111.

[73] Assignee: Abbott Laboratories, North Chicago, 111.

[22] Filed: Dec. 4, 1970 [21] Appl. No.: 95,012

[52] US. Cl. ..128/347, 128/2144, 128/348 [51] Int. Cl. ..A61b 17/34,A6lm 25/00 [58] Field of Search...128/213, 214.4, 215, 221, 303,

[56] References Cited UNITED STATES PATENTS 3,459,188 8/1969 Roberts..128/347 3,547,119 12/1970 Hall et a1. ..128/2l4.4

2,393,003 1/1946 Smith ..128/349 37,023 11/1862 Woolley ..128/321 51Oct. 17,1972

3,469,580v 9/1969 Huddy ..128/215 Primary Examiner-Dalton L. TruluckAttorneySherman and Shalloway [57] ABSTRACT A catheter assembly forperitoneal insertion, including an elongated stylet, an elongatedcatheter slidably disposed around the stylet and a gripping membersecured to a proximal end of the stylet and having a handle gripextending transversely therefrom adjacent a shank of the stylet suchthat the handle grip may be grasped in the palm of one hand with thefingers grasping the catheter adjacent a. distal end thereof whereby thecatheter assembly may be firmly held and guided with one hand duringperitoneal cavity insertion. Various embodiments of the catheterassembly include an elongated barrel surrounding the catheter having aclosed end anchored to the proximal end of the stylet, a stylet which isbent upon itself to form the gripping member, and a gripping memberdisposed parallel to the shank of the stylet and having an upper endbent upon itself and secured to the proximal end of the stylet.

12 Claims, 7 Drawing Figures PATENTEDQBI 17 m2 sum 1 OF 2 INVENTORS DEANR. KATERNDAHL EARL D. WILSON IIIIFIIIIIIIIIIIIIIII. I I l I I I'll I l ll I FIDEL v. MACALALAD GENE C. RING ATTORNEYS PATENTED 17 I97? 3 698 39SHEEI 2 BF 2 INV ENTORS N R KATERNDAHL EARL D. WILSO FIDEL V. MACALALADGENE C. RNG

CATHETER ASSEMBLY FOR PERITONEAL CAVITY INSERTION BACKGROUND OF THEINVENTION 1. Field of the Invention The present invention pertains tosurgical instruments and, more particularly, to a catheter assembly forperitoneal cavity insertion.

2. Background of the Invention With its surface area of approximately22,000 square centimeters, the human peritoneum is an excellentdialyzing membrane for removing excessive body wastes, excessive bodyfluid, excessive serum electrolytes, and toxic ingestions. This is notsurprising, since the peritoneal surface is approximately equal to thearea available for tubular filtration in the kidneys. Clinical studiesby many investigators have led to refinements in the dialyzing solutioncommonly employed, the substances which may be added on occasion, theequipment for instilling and removing the solution, and the schedule ofdialysis.

The essential steps of the basic procedure involved in peritonealdialysis are catheterization, instillation, dialysis, and drainage.Catheterization for peritoneal dialysis requires insertion of a catheterinto the peritoneal cavity with its tip in the area of the pelvicgutter. Generally, this is a simple matter of paracentesis and isperformed with an ordinary paracentesis set, using a trocar and cannula,often as a bedside procedure. Surgical insertion of the catheter withthe use of a trocar and cannula is preferred by some physicians. Strictaseptic technique should be utilized throughout the procedure. Themidline is usually chosen as the site for insertion of the trocar andcannula.

After sterile preparation of the desired site, the abdominal puncture ismade and the trocar is removed. A hollow metal cannula is then advancedto its full length so that only the proximal hub protrudes. (In verythin individuals, insertion of the set is often facilitated by priorinstillation of two liters of solution to distend the abdomen. This canbe accomplished with a large-bore needle No. l5 to 18.)

The catheter is then threaded through the cannula and the cathetermaneuvered into position, angling the cannula if necessary. The cathetermust be aimed so that the rounded tip lies in the pelvic gutter. Gentlemaneuvering will push aside omentum and establish a natural path. (Thisshould be done regardless of the insertion technique used.) When thecatheter is in place, the cannula is removed.

Next, 2 liters of peritoneal dialysis solution are attached to theadministration set, primed with dialysis fluid, and the catheterattached to the administration set. Occasionally, incomplete insertioncan be corrected by instilling one or two liters of solution and thenreadjusting the catheter. The area of insertion of the catheter iscovered with sterile dressing until the end of the procedure.

Insertion of the catheter without the use of the trocar and cannula ispreferred by most physicians. The device consists of a -12 inch long 1]Fr. plastic catheter with a metal stylet fitted inside. The pointed endof the stylet protruding out of the end of the catheter facilitatesinsertion into the peritoneal cavity. The small diameter of the cannulaand stylet will result in a catheter that is significantly flexible andin which to construct a catheter assembly which may be maniputheinsertion is difficult to control due to the length and flexibility ofthe catheter assembly. Several of the present devices on the market areprovided with a ring at the rear of the stylet to serve as a pressurepoint to assist in inserting the catheter assembly. However, the ring atthe rear of the stylet requires application of pressure up to 12 inchesaway from the point of insertion; and, with this long slender flexiblecatheter as sembly, the precise control required is lacking unless theother hand of the user is used. tocontrol the tip of the catheter. Toavoid this impractical aspect of catheter assemblies presentlyavailable, some users of such devices clamp the catheter and stylettogether at the rear to prevent the stylet point from retracting insidethe cannula and then make their insertion holding the catheter near itstip. This again, however, is a highly inconvenient and annoying featureand is one of the primary drawbacks of prior art devices.

SUMMARY OF THE INVENTION Accordingly, it is an object of the presentinvention lated with one hand during peritoneal insertion while bothapplying pressure to and guiding the catheter assembly.

The present invention is generally summarized in a catheter assembly forperitoneal insertion including an elongated stylet, an elongatedcatheter slidably disposed around the stylet, and a gripping memberhaving a support secured to the proximal end of the stylet and a handleextending transversely from the support and disposed adjacent the shankof the stylet whereby the handle may be grasped in the palm of one handwith the fingers of the hand grasping the stylet to provide guidance andpressure with one hand during peritoneal insertion.

Another object of the present invention is to construct a catheterassembly having a catheter of convenient length and a handlesufficiently close to the point of the stylet that the point of thestylet may be guided during insertion by the thumb and forefinger of thehand gripping the handle.

A further object of the present invention is to provide a catheterassembly wherein a stylet has a proximal end secured to a support memberextending along a shank of the stylet and a handle extending from thesupport member at a position near the distal end of the stylet to permitinsertion with one hand.

The present invention has another object in that a barrel for supportinga stylet has restrictions therein for maintaining a catheter in a firstposition sheathing the pointed distal end of the stylet and in a secondposition baring the pointed distal end of the stylet for insertion.

Some of the advantages of the present invention over the prior art arethat the catheter assembly is economically formed, that peritonealinsertions can be precisely made, that only one hand is required toprovide both guidance and pressure to the catheter assembly duringinsertion, and that aseptic technique is easily maintained.

Other objects and advantages of the present invention will becomeapparant from the following description of the preferred embodimentstaken in conjunction with the drawings.

BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is an exploded elevation,partially in section, of a catheter assembly according to the presentinvention.

FIG. 2 is an enlarged view, partially in section, of the closed end ofthe catheter assembly of FIG. 1.

FIG. 3 is a cross-section taken along line 3-3 of FIG. 1. 7

FIG. 4 is a cross-section taken along line 4-4 of FIG. 1.

FIG. 5 is a cross-section taken along line 55 of FIG. 1 with thecatheter and stylet in position.

FIG. 6 is an elevation of another embodiment of the present invention.

FIG. 7 is an elevation of a further embodiment of the present invention.

DESCRIPTION OF THE PREFERRED EMBODIMENTS A catheter assembly inaccordance with the present invention is illustrated in exploded view inFIG. 1 and includes an elongated, stainless steel, piercing stylet 10,an elongated, flexible plastic catheter 12 adapted to be slidablydisposed around stylet l and. a gripping member 14 adapted to receivestylet 10 and catheter 12.

Stylet 10 has a pointed distal end 16 and a flattened proximal end 18with a cylindrical shank 20 extending therebetween. Proximal end 18 isflattened such that it is wider than the diameter of shank 20 in orderto facilitate anchoring thereof in gripping member 14 as will beexplained hereinafter. Catheter 12 is a hollow, cylindrical tube and hasan inner diameter to accommodate stylet 10, as is illustrated in FIG.and, a rounded or tapered distal end 22 of catheter 12 is adapted to bedisposed adjacent distal end 16 of stylet while a proximal end 24 ofcatheter 12 is adapted to be disposed adjacent proximal end 18 of stylet10. Four rows of 25 0.020 inch diameter holes 23 are disposed incatheter 12 such that the total of one hundred holes 23 may be utilizedfor rapid diffusion and recovery of the dialysis fluid.

Gripping member 14 includes an elongated barrel 26 having a bore 28therein extending from an open end 30 to a closed end 32. Bore 28 has adiameter sufficient to permit catheter 12 to slide easily therein overstylet l0, and a pair of diametrically opposed restrictions 34 and 35constrict bore 28 at an extension 36 near closed end 32 of barrel 26, asis best illustrated in FIG. 4. An end bore 38 communicates withextension 36 defining a stop 37 therebetween and has a diameter tosnugly receive shank 20 of stylet 10. A pair of diametrically opposedslots 40 and 42 are longitudinally disposed along end bore 38; the widthof slots 40 and 42 being such as to snugly receive flattened proximalend 18 of stylet 10. A pair of diametrically opposed blind holes 44 and46 are positioned in barrel 26 adjacent closed end 32 in alignment withslots 40 and 42, respectively, as is best illustrated in FIG. 3.

Gripping member 14 is preferably molded of an appropriate plasticmaterial to integrally include a handle grip 48 extending transverselyfrom barrel 26 adjacent open end 30 and an inverted T-shapedstrengthening rib 50 which extends longitudinally along the bottom ofbarrel 26, looking at FIG. 1. Rib 50 terminates at closed end 32 intapered fashion and is incorporated in handle grip 48 as a flangeextending around the periphery thereof.

In assembly, stylet 10 is secured or anchored in gripping member 14 bysliding the stylet into bore 28 in barrel 26 such that the end of shank20 is inserted in end bore 38 and the flattened portion of proximal end18 is inserted in slots 40 and 42. With the stylet 10 so inserted inbarrel 26, hot staking pins are pushed into blind holes 44 and 46 tomelt the plastic material and force a mass of the plastic material oneither side of barrel 26 into slots 40 and 42 to anchor the proximal end18 with the gripping member. After stylet 10 is secured in the grippingmember, catheter 12 is slid into bore 28 around stylet 10 until proximalend 24 of catheter 12 is moved slightly into extension 36 beyondrestrictions 34 and 35. The length of catheter 12 will be such that whenend 24 of the stylet is so positioned, distal end 22 sheathes thepointed distal end 16 of stylet l0. Catheter 12 is held in place by thedeforming of the proximal end 24 in extension 36 which has a crosssection shape such as to compress catheter 12 against stylet 10; and,with the catheter assembly as above described, the assembly willnormally be placed in a sterile package.

When it is desired to utilize the catheter assembly, it is removed fromthe sterile package, and the catheter 12 is pushed further into barrel26 such that proximal end 24 abuts stop 37. The length of extension 36is such that with catheter 12 fully inserted in ba'rrel 26 to abut stop37, distal end 22 will be positioned on shank 20 adjacent distal end 16of the stylet 10 to bare the pointed distal end for piercing.

The user of the catheter assembly grips handle 48 with the palm of onehand and, with the forefinger and thumb of the hand, grasps the roundeddistal end 22 of the catheter such that pointed distal end 16 of stylet10 may be securely held and placed at the point of insertion with onehand. Pressure may thus be applied to the catheter assembly via handle48 while simultaneously controlling the point of insertion with thethumb and forefinger of the same hand, and it will be appreciated thataccurate insertion of the catheter through the peritoneum of the patientmay be accomplished with one hand.

After proper insertion of the catheter, the user holds the catheter 12with one hand while moving gripping member 14 away from the point ofinsertion such that gripping member 14 and stylet 10 are removed whilecatheter 12 is advanced into the area of the pelvic gutter. Thus, aconvenient length of catheter 12 is available for administration.

Another embodiment of a catheter assembly accord ing to the presentinvention is illustrated in FIG. 6, and parts of the embodiment of FIG.6 identical to parts of the embodiment of FIGS. 1-5 are given identicalreference numbers and not described again. Parts of the embodiment inFIG. 6 which are similar to parts of the embodiment of FIGS. 1-5 aregiven reference numbers with added.

In the embodiment of FIG. 6, a gripping member 1 14 is formed as anextension of, and integrally with, stylet 10. That is, the shank ofstylet 10 which slidably receives catheter 12 is bent at an acute angleat proximal end 18 to form a support member 100 extending along theshank toward the distal end 16. An arcuate handle grip 148 is formedfrom the end of support member 100 to extend generally in a directiontransverse thereto.

The catheter assembly of FIG. 6 is utilized in a manner similar to thatdescribed with respect to the catheter assembly of FIGS. l-S in thathandle grip 148 is grasped with the palm of one hand and the thumb andforefinger are utilized to grip catheter 12 near distal end 22 in orderto permit guidance and pressure on the catheter assembly with one handduring peritoneal insertion.

A further embodiment of a catheter assembly according to the presentinvention is illustrated in FIG. 7, and parts of the embodiment of FIG.7 identical to parts of the embodiment of FIGS. 1-5 are given identicalreference numbers and not described again. Parts of the embodiment inFIG. 7 which are similar to parts of the embodiment of FIGS. l-5 aregiven reference numbers with 200 added.

The primary difference between the embodiment of FIG. 7 and theembodiment of FIG. 6 is that a gripping member 214 is formed separatelyfrom stylet 10 rather than integrally therewith. The upper end 200 ofgripping member 214 is bent upon itself and molded to have slotstherein, similar to slots 40 and 42 in the embodiment of FIGS. 15. Theflattened proximal end 18 of stylet 10 is inserted in the slots andanchored to gripping member 214 such as by the use of hot staking pins.A support member 202 extends from end 200 along shank 20 of stylet 10 toan arcuate handle grip 248 which extends transversely therefrom.Catheter 12 is slidably positioned on stylet 10 for insertion therewith.

In use, the catheter assembly of FIG. 7 has the same advantages aspreviously described with respect to the embodiments of FIGS. 1-5 andFIG. 6, in that the user may grasp handle grip 248 with the palm of onehand while squeezing catheter 12 adjacent distal end 22 to grip stylet10 and properly position and apply pressure to the catheter assemblywith one hand.

In each of the embodiments illustrated in FIGS. 6 and 7, the proximalend 18 of stylet 10 may be enlarged in order to form a stop againstwhich the proximal end 24 of catheter 12 can be positioned to ensurethat the rounded distal end 22 will form a sheath over the pointeddistal end 16 of the stylet during shipping of the catheter assembly.

It will be appreciated that all of the above described catheterassemblies permit peritoneal cavity insertion of a catheter with onlyone hand due to the positioning of a handle grip adjacent the shank of astylet such that the stylet can be grasped near its pointed distal endwith the fingers of one hand while the handle grip is held with the palmof the same hand. Specifically, the proximal end of the stylet isanchored with a gripping member to prevent rotational or longitudinalmovement therebetween; and in the embodiment of FIGS. 1-5, the handlegrip is supported at the open end of a barrel through which the shank ofthe stylet extends whereas in the embodiments of FIGS. 6 and 7 a supportmember extends along the shank of the stylet to support the handle gripat a position adjacent the shank of the stylet.

The lengths of the stylet, the catheter and the gripping member may bevaried dependent upon the desired use of the catheter assembly; however,the catheter will normally have a length of from ten to twelve inchesfor peritoneal insertion. The stylet will, of course, be slightly longerthan the catheter to permit the pointed distal end of the stylet toextend beyond the distal end of the catheter, and the gripping memberwill have a length such that the handle grip is spaced approximately 4inches from the pointed distal end of the stylet.

Inasmuch as the present invention is subject to many variations,modifications and changes in detail, it is intended that all matterdescribed in the foregoing specification or shown in the accompanyingdrawings shall be interpreted as illustrative and not in a limitingsense.

What is claimed is:

1. A catheter assembly for peritoneal cavity insertion comprising anelongated stylet having a pointed distal end, a

proximal end and a shank extending therebetween; an elongated catheterslidably disposed around said shank of said stylet; and

" gripping means for holding said stylet, said gripping means includingsupport means secured to said proximal end of said stylet and handlemeans of a size to be grasped by a hand, said handle means extendingtransversely from said support means and disposed adjacent said shank ofsaid stylet intermediate and spaced from said proximal and distal endswhereby said handle means may be grasped in the palm of one hand withthe fingers of the hand grasping said stylet such. that said catheterassembly may be firmly held in one hand to provide guidance and pressureduring peritoneal cavity insertron.

2. The invention as recited in claim 1 wherein said support meansincludes an elongated barrel surrounding said stylet and having a closedend and an open end, said proximal endof said stylet being secured insaid closed end of said barrel, said shank of said stylet extendingthrough said open end of said barrel, and said handle means including agrip member extending transversely from said barrel at said open end.

3. The invention as recited in claim 2 wherein said barrel has a boretherein having a diameter slightly larger than the diameter of saidcatheter such that said catheter is slidable in said bore, said borehaving an extension of reduced cross section at said closed end of saidbarrel, and said catheter having a length slightly less than the lengthof said stylet and a first end disposed at said closed end of saidbarrel and a second end disposed at said distal end of said stylet, saidsecond end of said catheter covering said distal end of said stylet whensaid first end of said catheter is ad jacent said reduced extension ofsaid bore and said reduced extension of said bore having a lengthsufficient to permit said second end of said catheter to bare saiddistal end of said stylet when said first end of said catheter tube issqueezed further into said reduced extension of said bore.

4. The invention as recited in claim 2 wherein said proximal end of saidstylet is fiat and has a width greater than the diameter of said shank,and said closed end of said barrel has a pair of slots therein, saidflat proximal end being received and anchored in said slots whereby saidstylet is prevented from rotational or longitudinal movement withrespect to said barrel.

v5. The invention as recited in claim 4 wherein said barrel has a boretherein having a diameter slightly larger than the diameter of saidcatheter such that said catheter is slidable in said bore, said borehaving an extension of reduced cross section at said closed end of saidbarrel, and said catheter has a length slightly less than the length ofsaid stylet and a first end disposed at said closed end of said barreland a second end disposed at said distal end of said stylet, said secondend of said catheter covering said distal end of said stylet when saidcatheter is adjacent said reduced extension portion of said bore andsaid reduced extension of saidbore having a length sufficient to permitsaid second end of said catheter to bare said distal end of said styletwhen said first end of said catheter is squeezed into said reducedextension of said bore.

6. The invention as recited in claim 5 wherein a flatreinforcing rib isintegrally formed with said barrel and runs along the longitudinallength of said barrel from said closed end to said handle grip.

7. The invention as recited in claim 6 wherein said barrel, said gripmember and said reinforcing rib are integrally formed of a plasticmaterial.

8. The invention as recited in claim 4 wherein said barrel is made of aplastic material and has first and second blind holes disposed thereinin diametrically opposed relation at said closed end to define a mass ofplastic between each of said slots and each of said blind holes,respectively, whereby said masses of material may be melted to anchorsaid stylet to said barrel.

9. The invention as recited in claim 1 wherein said stylet is bent uponitself at said proximal end to define said support means and saidstylet, said support means and said handle means are integrally formed.

10. The invention as recited in claim 1 wherein said support meansincludes a support member disposed parallel to said shank of saidstylet, said support member having a first end bent upon itself andanchored to said proximal end of said stylet and a second endterminating at an arcuate handle grip defining said handle means. i

11. The invention as recited in claim 1 wherein said support meansextends along said shank of said stylet in parallel relation therewith.

12. The invention as recited in claim 1 wherein said handle means isspaced substantially four inches from said distal end of said stylet.

1. A catheter assembly for peritoneal cavity insertion comprising anelongated stylet having a pointed distal end, a proximal end and a shankextending therebetween; an elongated catheter slidably disposed aroundsaid shank of said stylet; and gripping means for holding said stylet,said gripping means including support means secured to said proximal endof said stylet and handle means of a size to be grasped by a hand, saidhandle means extending transversely from said support means and disposedadjacent said shank of said stylet intermediate and spaced from saidproximal and distal ends whereby said handle means may be grasped in thepalm of one hand with the fingers of the hand grasping said stylet suchthat said catheter assembly may be firmly held in one hand to provideguidance and pressure during peritoneal cavity insertion.
 2. Theinvention as recited in claim 1 wherein said support means includes anelongated barrel surrounding said stylet and having a closed end and anopen end, said proximal end of said stylet being secured in said closedend of said barrel, said shank of said stylet extending through saidopen end of said barrel, and said handle means including a grip memberextending transversely from said barrel at said open end.
 3. Theinvention as recited in claim 2 wherein said barrel has a bore thereinhaving a diameter slightly larger than the diameter of said cathetersuch that said catheter is slidable in said bore, said bore having anextension of reduced cross section at said closed end of said barrel,and said catheter having a length slightly less than the length of saidstylet and a first end disposed at said closed end of said barrel and asecond end disposed at said distal end of said stylet, said second endof said catheter covering said distal end of said stylet when said firstend of said catheter is adjacent said reduced extension of said bore andsaid reduced extension of said bore having a length sufficient to permitsaid second end of said catheter to bare said distal end of said styletwhen said first end of said catheter tube is squeezed further into saidreduced extension of said bore.
 4. The invention as recited in claim 2wherein said proximal end of said stylet is flat and has a width greaterthan the diameter of said shank, and said closed end of said barrel hasa pair of slots therein, said flat proximal end being received andanchored in said slots whereby said stylet is prevented from rotationalor longitudinal movement with respect to said barrel.
 5. The inventionas recited in claim 4 wherein said barrel has a bore therein having adiameter slightly larger than the diameter of said catheter such thatsaid catheter is slidable in said bore, said bore having an extension ofreduced cross section at said closed end of said barrel, and saidcatheter has a length slightly less than the length of said stylet and afirst end disposed at said closed end of said barrel and a second enddisposed at said distal end of said stylet, said second end of saidcatheter covering said distal end of said stylet when said catheter isadjacent said reduced extension portion of said bore and said reducedextension of said bore having a length sufficient to permit said secondend of said catheter to bare said distal end of said stylet when saidfirst end of said catheter is squeezed into said reduced extension ofsaid bore.
 6. The invention as recited in claim 5 wherein a flatreinforcing rib is integrally formed with said barrel and runs along thelongitudinal length of said barrel from said closed end to said handlegrip.
 7. The invention as recited in claim 6 wherein said barrel, saidgrip member and said reinforcing rib are integrally formed of a plasticmaterial.
 8. The invention as recited in claim 4 wherein said barrel ismade of a plastic material and has first and second blind holes disposedtherein in diametrically opposed relation at said closed end to define amass of plastic between each of said slots and each of said blind holes,respectively, whereby said masses of material may be melted to anchorsaid stylet to said barrel.
 9. The invention as recited in claim 1wherein said stylet is bent upon itself at said proximal end to definesaid support means and said stylet, said support means and said handlemeans are integrally formed.
 10. The invention as recited in claim 1wherein said support means includes a support member disposed parallelto said shank of said stylet, said support member having a first endbent upon itself and anchored to said proximal end of said stylet and asecond end terminating at an arcuate handle grip defining said handlemeans.
 11. The invention as recited in claim 1 wherein said supportmeans extends along said shank of said stylet in parallel relationtherewith.
 12. The invention as recited in claim 1 wherein said handlemeans is spaced substantially four inches from said distal end of saidstylet.